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Active substance(s): MESALAZINE

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PENTASA® Mesalazine Enema

Patient Information
Read all of this leaflet carefully before you start taking
this medicine.

− Keep this leaflet. You may need to read it again
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
− If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
In this leaflet :
1. What Pentasa is and what it is used for
2. Before you use Pentasa
3. How to use Pentasa
4. Possible side effects
5. How to store Pentasa
6. Further Information

The name of this medicine is Pentasa Mesalazine Enema in the
form of a suspension. Each bottle contains mesalazine 1g in100ml
of liquid as the active ingredient. Mesalazine belongs to a group of
medicines called salicylates.
Pentasa is used to treat inflammation in the gut caused by
conditions such as active ulcerative colitis where it is affecting the
last part of the colon and rectum (back passage).
The enema releases the active ingredient which then acts locally to
reduce the inflammation and help relieve or stop the pain.

Pregnancy and Breast-feeding
If you are pregnant, planning to become pregnant or are breastfeeding you should speak to your doctor or pharmacist for advice
before taking this medicine.
There is limited experience with the use of mesalazine during
pregnancy and breast-feeding. The newborn may develop allergic
reactions after breast-feeding, e.g. diarrhoea. If the newborn
develops diarrhoea, breast-feeding should be discontinued.

For Adult use only, not recommended in children.
Always use Pentasa exactly as your doctor has told you. You
should check with your doctor or phamacist if you are not sure. The
enema should be used in the back passage (rectum) only. Usually
your doctor will ask you to use one enema at bedtime.
How to use the enema
1. Immediately before use take the enema bottle out
of the aluminium foil pack and shake it well

2. To break the seal twist the nozzle clockwise one
full turn (the nozzle should then be in the same
direction as before turning).

3. Put your hand in one of the plastic disposal bags
provided in the pack

Do Not use Pentasa if you :
• are allergic to mesalazine or any of the other ingredients in
Pentasa (see section 6)
• are allergic to any other salicylates e.g. Aspirin
• have severe liver or kidney problems

4.Hold the container as shown in the picture.

Pentasa is not suitable for use in children

Take special care with Pentasa
You should consult your doctor before using these enemas if:
• you currently have, or have previously had liver or kidney
• you are on any medication that may affect kidney function
e.g. azathioprine
• you have ever had an allergy to a medication called
• If you have lung problems, in particular asthma.
While you are using Pentasa your doctor may occasionally want to
check your kidney function.
If you suddenly develop abdominal cramps, abdominal pain, fever,
severe headache and rash, stop using this medicine and seek
medical advice immediately.
You should make sure that you don’t become dehydrated, while
you are using this medicine. This can occur after severe or
prolonged attacs of vomiting and/or diarrhoea, high fever or heavy
sweating. If this does occur, you should speak to a doctor or
pharmacist for advice as soon as possible.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any of the following:
• Azathioprine, 6-mercaptopurine or thioguanine
• Certain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g.warfarin)

5. To administer the enema, lie on
your left side with the left leg straight
and the right leg bent forward for
balance. Carefully insert the applicator
tip into the rectum. Maintain sufficient
steady hand pressure while dispersing
the bottle content. The bottle content
should be applied within max. 30-40
6.Once the bottle is empty, withdraw the tip with the bottle still
7. The enema should be retained
in the bowel. Remain relaxed in
the administration position for 5-10
minutes or until the urge to pass the
enema has disappeared.

8. Roll the plastic disposal bag over the empty
bottle. Discard it and wash your hands.

Please note: Pentasa Mesalazine may cause permanent staining
on contact with clothing or fabrics.

If you use more Pentasa than you should
If you accidentally use too much, you should go to your nearest
emergency department or contact your doctor immediately. Take
the carton with you.
If you forget to use Pentasa
If you forget to use a dose, use the next dose in the morning if it is
convenient. Otherwise, use one as usual the next night. Do not use
a double dose to make up for the forgotten one.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Like all medicines, Pentasa can cause side effects although not
everyone gets them.
Following rectal administration local reactions such as itching
rectal discomfort and urge may occur.
STOP taking Pentasa if you notice:
• Itching,skin rashes, swelling of the face, lips or throat, difficulty in
breathing or wheeziness (signs of an allergic reaction).
• Skin disorder due to an allergic reaction or infection (Erythema
mulitforme or Stevens-Johnson syndrome).
Symptoms include severe rash, blisters or red splotches on the
• Unexplained bleeding, brusing, skin rashes, fever or sore throat
(signs of blood disorder).
• Change in colour or amount of urine produced (signs of kidney
• Chest pain, an increase in heartbeat or excess tiredness (signs
of heart problems).
• Inflammation of the liver or liver failure, symptoms include
yellowing of the eyes and/or skin (Jaundice), dark urine, stomach
pain, fever, feeling tired or nausea.
• Inflammation of the pancreas, symptoms include back and/or
stomach pain, fever, nausea and vomiting.
• Ulcerative colitis involving the entire large intestine.
If you experience any of the above side effects you should contact
your doctor or go to the nearest hostpital emergency department
Common side effects
(may affect up to 1 in 10 people)
• rash with our without itching
Rare side effects
(may affect up to 1 in 1,000 people)
• vomiting
• stomach pain
• nausea
• diarrhoea
• headache
• inflammation of the heart or area surrounding the heart
• dizziness
• flatulence (passing wind)
• raised level of a pancreatic enzyme
• Increased sensitivity of your skin to sun and ultraviolet light
Very rare side effects
(may affect up to 1 in 10,000 people)
• raised liver enzymes
• hair loss (reversible)
• joint and muscle pain
• allergic reactions and fever
• lupus erythematosis (an auto-immune disorder effecting
the skin)
• skin rash or blisters e.g.Erythema Multiforme or
Steven-Johnson syndrome
• semen with a low concentration of sperm (oligospermia)
(this is reversible)
• blood disorders (e.g. low levels of red blood cells)
• tingling or numbness in the hands and feet
• allergic and fibrotic lung reactions (including breathing
• changes in kidney function or kidney failure
• inflammation of the pancreas

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme,
website:, or search for MHRA Yellow
Card in the Google Play or Apple App Store. By reporting side
effects you can help provide more information on the safety of this

Do not store above 25ºC.

Keep the foil packed bottles in the outer carton in order to protect
them from light.
Do not use after the expiry date detailed on the pack.
Keep out of sight and reach of children.

Return any old or unused medicines to your pharmacist for

What Pentasa contains
Each bottle contains 1g of the active ingredient, mesalazine in
100ml of liquid. The mesalazine settles out as a separate layer. It
also contains the following inactive ingredients: disodium edetate,
sodium metabisulphite, sodium acetate, hydrochloric acid, purified
What Pentasa looks like and the contents of the pack
The enema is a colourless to faint yellow suspension presented
in a polythene bottle. Each pack contains 7 individually foilwrapped enema bottles and 7 polythene bags for disposal of the
empty enema bottle after use.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road,
West Drayton, UB7 7PS, UK.
Manufactured by
Ferring A/S, DK-2720 Vanløse, Copenhagen, Denmark.
PENTASA Mesalazine Enema PL 03194/0027
This leaflet was last revised in January 2018.
PENTASA is a registered trademark

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.